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NCT ID: NCT04132453 Completed - Clinical trials for Blood Pressure Measurement

Continuous Blood Pressure and Waveform Measurements Comparison Between Invasive Arterial Line and PPG Sensor

Start date: June 19, 2018
Phase:
Study type: Observational

The purpose of this study is to compare blood pressure values (systolic, diastolic, mean arterial pressure) and waveform as recorded by a radial arterial line catheter to the waveform and values as calculated by the Sensifree's algorithm from a PPG sensor from a variety group of patients during elective surgeries.

NCT ID: NCT04130191 Active, not recruiting - Clinical trials for Hereditary Angioedema (HAE)

A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II

ENABLE
Start date: December 11, 2019
Phase:
Study type: Observational

The main aim of this study is to compare the number of HAE attacks occuring in persons using lanadelumab with the number of HAE attacks before lanadelumab treatment was started. Data from participants who start the study after 1 March 2021, will be collected for 24 months; data from all other participants (who started the study before 1 March 2021) will be collected for 36 months. Participants will report information in a smartphone application at study start and for the next 3 months and then every 6 months until the study ends; data will also be collected by the study doctor during routine clinic visits

NCT ID: NCT04129892 Recruiting - Preventive Therapy Clinical Trials

In Favor of My Resilient Self- Effects of an Academic Course on the Emotional Resilience of Students.

Start date: August 3, 2019
Phase: N/A
Study type: Interventional

The course " In Favor of My Resilient Self" will guide participants to develop their strength sources, as well as practice self-calming and self-controlling exercises. The main goals of the course are to: 1. Measure the effects on the emotional resilience and confidence of participants. 2. Assess differences in the course's affect on students from the faculty of sciences compared with students from the faculty of social studies. 3. Understand the mechanisms of the effects. Results will be measured using the study questionnaire, to be filled out by the participants before, after, and three months after the completion of the course.

NCT ID: NCT04129502 Active, not recruiting - Clinical trials for Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

Start date: January 10, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group. Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.

NCT ID: NCT04129489 Terminated - Clinical trials for Autoimmune Hepatitis

A Phase 2a Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis

Start date: February 7, 2019
Phase: Phase 2
Study type: Interventional

Subjects with stable autoimmune hepatitis disease currently being administered corticosteroids with or without azathioprine (AZA) treatment will be be treated with Cannabidiol instead of standard of care treatment with corticosteroids

NCT ID: NCT04128696 Terminated - Clinical trials for Neoplasms, Head and Neck

Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

INDUCE-3
Start date: November 21, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) >=1 R/M HNSCC.

NCT ID: NCT04127877 Recruiting - Clinical trials for Chronic Kidney Diseases

Bio Impedance-assisted Monitoring of Chronic Hemodialysis Patients

Start date: November 18, 2018
Phase: N/A
Study type: Interventional

Hemodynamic trends will be assessed using the device, in 100 dialysis sessions in 30 patients, who are prone to develop hypotensive episode during dialysis. Sitting blood pressures will be measured immediately prior to each hemodynamic measurement: before initiation of dialysis, every each hour and in the beginning of hypotension episode, just before the end and 10 min after the end of the treatment. Gender, age, height, weight, electrode location and blood pressure data will be entered into the device. The device will measure and calculate hemodynamic parameters on each heart beat during 60 s and provides the averaged parameters. Technology for hemodynamic measurements: The device (NICaS, NI Medical) is a noninvasive regional bioimpedance cardiac measurement and analysis system (FDA 510k clearance no. K080941, 12 June 2009). The US Food and Drug Administration indication for use of the device states 'NICaS is intended to monitor and display hemodynamic parameters in males and females with known or suspected cardiac disorders needing cardiac assessment'. SV will be measured by applying an alternating electrical current of 1.4mA at 30 kHz frequency through the patient's body via two pairs of tetrapolar sensors, one pair placed on the wrist of the nonaccess arm above the radial pulse and the other pair on the contralateral ankle above the posterior tibial pulse (Figure 1). Figure 1 : Sensor location SV is calculated by Frinerman's formula: SV¼(dR/R) - q - (L2/Ri) - (ab)/b - KW - HF [2-4], where dR is the impedance change in the arterial system as a result of intraarterial expansion during systole, R is basal resistance, q is blood electrical resistance, L is the patient's height, Ri is basal resistance corrected for gender and age, KWis the correction of weight according to ideal values, HF is a hydration factor that takes into account the ratio between R and body mass index (BMI), which is correlated to body water volume, ab is the electrocardiogram (ECG) R-R wave interval and b is the diastolic time interval. SV is automatically calculated every 20 s and is the average of three measurements obtained consecutively during 60 s of monitoring. The SV index is calculated as SV/body surface area using the Du Bois formula [11]. Heart rate is calculated from a one channel ECG and cardiac (output) index¼SV index - heart rate/1000. Using an oscillometric method, sitting systolic and diastolic blood pressure measurements were made automatically by the dialysis machine. Mean arterial pressure [2 - (diastolicsystolic)/3], cardiac power index [CPI; mean arterial pressure (MAP) -cardiac index - 0.0022 w/m2; normal range 0.45-0.85w/m2] [12, 13] and total peripheral resistance (MAP/ cardiac index - 80 dyn - s/cm5 - m2; normal range 1600-3000 dyn - s/cm5- m2) [13] will be calculated. As the device measures pulsatile flow and is blinded to constant flow, fluid removal during dialysis has no impact on measurement accuracy. This was recently validated by correlating SV to ECG measurements during hemodialysis treatments. Good correlation was maintained during treatment. Further, NICaS performance immunity to fluid reduction was demonstrated by the maintenance of correlation to ECG results throughout dialysis treatments [9]. The results are drawn on hemodynamic graphs showing the MAP (y-axis) as a function of cardiac index (x-axis); curves of total peripheral resistance index (TPRI) and CPI are displayed. Ranges for the normal population are depicted by a dotted octagon.

NCT ID: NCT04127578 Recruiting - Parkinson Disease Clinical Trials

Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)

Start date: January 3, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Study J3Z-MC-OJAA is a Phase 1/2a, multicenter, open-label, ascending dose, first in-human study that will evaluate the safety of intracisternal LY3884961 administration in patients with moderate to severe Parkinson's disease with at least 1 pathogenic GBA1 mutation. Two dose level cohorts of LY3884961 are planned (Dose Level 1 and Dose Level 2). The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of LY3884961 on safety, tolerability, immunogenicity, biomarkers, and clinical efficacy measures. Patients will continue to be followed for an additional 4 years to continue to monitor safety as well as selected biomarker and efficacy measures.

NCT ID: NCT04127006 Active, not recruiting - Clinical trials for Retinitis Pigmentosa

Rate of Progression in EYS Related Retinal Degeneration

Pro-EYS
Start date: February 25, 2020
Phase:
Study type: Observational

The overall goal of this project funded by the Foundation Fighting Blindness is to characterize the natural history of disease progression in patients with EYS mutations in order to accelerate the development of outcome measures for clinical trials.

NCT ID: NCT04126473 Completed - Cystic Fibrosis Clinical Trials

A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allele

Start date: November 5, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2 open label study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 with and without ivacaftor in patients with CF with at least one G542X allele or phenotypically similar nonsense allele. Up to 16 patients will be enrolled in the trial; up 4 patients will be homozygotes to G542X, and the remaining patients will be compound heterozygotes with G542X or phenotypically similar nonsense mutation and any Class 1 or Class 2 mutation. Each patient will receive 5 escalating doses as follows: - 0.3 mg/kg per day SC - 0.75 mg/kg per day SC - 1.5 mg/kg per day SC - An individualized dose, as high as 3.0 mg/kg per day SC, based upon the patients observed safety and tolerability, PK at previous doses and the results of laboratory tests - ELX-02 1.5 mg/kg per day SC plus 150 mg ivacaftor every 12 bid